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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOLOGIC, INC NOVASURE STERILIZED AND SURESOUND; DEVICE, THERMAL ABLATION, ENDOMETRIAL
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HOLOGIC, INC NOVASURE STERILIZED AND SURESOUND; DEVICE, THERMAL ABLATION, ENDOMETRIAL Back to Search Results
Model Number 2013
Device Problem Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/07/2023
Event Type  Injury  
Event Description
It was reported that on november 7th a novasure procedure was performed and after the ablation, the doctor noted a piece of the mesh left behind in the cavity.The doctor removed all pieces of the mesh until nothing left behind.No additional information available.
 
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Brand Name
NOVASURE STERILIZED AND SURESOUND
Type of Device
DEVICE, THERMAL ABLATION, ENDOMETRIAL
Manufacturer (Section D)
HOLOGIC, INC
250 campus drive
marlborough MA 01752
Manufacturer (Section G)
HOLOGIC, INC.
250 campus drive
marlborough MA 01752
Manufacturer Contact
ariel lafuente
562 parkway
coyol free zone building b24
san jose 20102
CR   20102
MDR Report Key18191268
MDR Text Key328795148
Report Number1222780-2023-00444
Device Sequence Number1
Product Code MNB
UDI-Device Identifier15420045501119
UDI-Public(01)15420045501119(17)250827(10)23H08RM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2013
Device Catalogue NumberNS2013KITUS
Device Lot Number23H08RM
Was Device Available for Evaluation? No
Date Manufacturer Received11/07/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexFemale
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